Medical device Regulations In Europe 80% Baked In Even if Not Formally Adopted
In Europe, growing public ire over the breast implant scandal and the high rate of failures of the metal-on-metal hip implants prompted the European Commission in September 2012, to put forth two proposals from the European Parliament and Council to change the way medical devices and in vitro diagnostic products are regulated.
Although a final vote hasn’t occurred, “80% of the regulation has been designed and will not change,” said Jean-Pierre Boutrand, vice president of sales at contract research organization and consulting firm NAMSA, at the annual Lifescience Alley Conference in Minneapolis on Wednesday. The new rules will go into effect between 2015 and 2018 assuming the regulations are adopted early next year.
The proposals constitute significant changes since the 1990s when three Medical Device Directives established the legal framework for regulating devices across the Atlantic, Boutrand said.
Many had worried that Europe would centralize device regulation following in the footsteps of the U.S., but while the proposals show a tightening of the regulatory framework, it still retains the functioning of the notified bodies – the third party reviewers that have historically approved medical devices in Europe – in lieu of a central regulating agency akin to the FDA.
This was probably because Europe wants to retain its edge over the U.S. regulatory system, which can be riddled with delays. Boutrand referred to a Boston Consulting Group analysis that found that between 2000 and 2005, companies received CE Mark 38 months before the corresponding green light from the FDA. Between 2006 and 2011 the gap increased further to 47 months.
While the time to market may not change that much for most device, the new regulations, if adopted, signal a new era where the system for CE Mark will become more stringent than in the past.
For instance, expect to be provide more clinical data on submissions, Boutrand said, and expect more questions. This is especially true of Class III devices and implantables. In Europe, many clinical submissions for Class IIb and Class III devices aren’t accompanied by clinical evidence, Boutrand explained.
Notified bodies are going to undergo major changes. Two new bodies are being created – the Medical Device Coordination Group, which among other things would provide greater scrutiny of the notified bodies, and the Assessment Committee for Medical Devices, which would review higher-risk medical devices on a case-by-case basis, Boutrand said.
Already certain changes are being being felt. Out of the 75-odd notified bodies in Europe, 12 were audited over the past two years. Of them, three have voluntarily denotified and there are questions about 2 others whom he expects will either voluntarily or by pressure, get denotified, Boutrand explained.
Overall, the regulations are meant to provide greater patient safety while at the same time “support innovation and rapid access to market,” the hallmarks of the CE Mark system, Boutrand said.